ABBOTT PARK, Ill., Nov. 8, 2010 /PRNewswire-FirstCall/ -- Today, Abbott (NYSE: ABT) presents results from a pooled analysis of two pivotal HUMIRA® (adalimumab) studies, which look at patients with early and long-standing moderate to severe rheumatoid arthritis (RA), at the American College of Rheumatology meeting in Atlanta.
The study looked at inflammation and structural damage of the joints in early and long-standing RA and their relationship with deteriorating physical function in each stage of the disease. In patients with early RA (less than three years), inflammation was more strongly correlated to worsening physical function than in patients with long-standing RA. Structural damage showed stronger correlation to worsening physical function in long-standing RA compared to early RA.
"We know that RA is a progressive disease, and for years we've hypothesized about what is driving these changes in physical function," said Primary Investigator Martin Bergman, M.D., clinical associate professor of medicine, Drexel University College of Medicine and chief of the division of rheumatology at Taylor Hospital. "These data are important because they can help advance our understanding of how RA changes over time."
RA is a chronic autoimmune disease that affects approximately 1.3 million people in the U.S. Typically, RA is characterized by pain, swelling and stiffness in the joints of hands, feet and wrists and often leads to the erosion of joints.
"These data and analyses provide additional insights into RA which we hope will inform better patient care in the future," said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott.
Specifically, the analysis evaluated data from two HUMIRA trials – PREMIER (patients with early RA) and DE019 (patients with long-standing RA). There were 908 patients with disease duration three years or less and 507 patients with disease duration of more than three years. The study assessed the relationship of physical functioning with inflammation and structural damage.
Commonly used methods of patient reported measures calculated physical functioning. The measures include the 20 question Health Assessment Questionnaire (HAQ) and two components of the well-known, health-related quality of life questionnaire SF-36: the physical function scale (PF) and the physical component summary (PCS).
Inflammation was measured by C-Reactive Protein (CRP) levels and structural damage was measured by modified total Sharp scores (mTSS), a well-established method of assessing structural joint damage.
In the early RA disease group, all indicators of physical function were significantly correlated to CRP readings measuring inflammation (HAQ, PCS, and PF correlation co-efficients of 0.395, -0.288 and -0.357, respectively [p value = <0.05 for all]), but none correlated to mTSS scores measuring structural damage. In the long-standing RA disease group, mTSS was significantly correlated with physical functioning measures (HAQ, PCS, and PF correlation co-efficients of 0.238, -0.119, and -0.137, respectively [p value = <0.01]). The inflammation CRP levels were also correlated to physical functioning in the long-standing RA group, but this correlation was weaker than in the early RA group. Additionally, a linear regression analysis, a second analysis of the data, showed that mTSS affects HAQ in long-standing disease, but not early RA.
HUMIRA RA Indication
HUMIRA is used to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults, may prevent further damage to bones and joints, and may help the ability to perform daily activities. HUMIRA can be used alone or with methotrexate or with certain other medicines. HUMIRA is taken by injection and is available by prescription only.
HUMIRA Important Safety Information
HUMIRA is a TNF blocker that affects the immune system, and can lower the ability to fight infections. Patients treated with HUMIRA are at an increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were also taking other medicines that suppress the immune system, such as methotrexate or corticosteroids. Reported infections include tuberculosis (TB), and infections caused by viruses, fungi or bacteria that have spread throughout the body. Patients should be tested for TB before HUMIRA use and during therapy, and treatment for latent infection should be initiated prior to HUMIRA use. Treatment with HUMIRA should not be started in patients with active infections. HUMIRA should be stopped if a patient develops a serious infection. There have been cases of lymphoma and other cancers, some fatal, in children and adolescents receiving TNF blockers. For children and adults taking TNF blockers, including HUMIRA, the chances of getting lymphoma or other cancers may increase. Other possible serious side effects with HUMIRA include: allergic reactions, reactivation of hepatitis B in patients who are chronic carriers (some fatal), nervous system problems, blood problems, new or worsening heart failure or psoriasis and immune reactions including a lupus-like syndrome. The combination of HUMIRA and anakinra is not recommended. Patients using HUMIRA should not receive live vaccines.
The most common side effects in HUMIRA clinical trials, reported at a rate of greater than 10 percent, were: infections (e.g. upper respiratory, sinusitis), injections site reactions, headache and rash. As with any treatment program, the benefits and risks of HUMIRA should be carefully considered before starting therapy. Full Prescribing Information for HUMIRA is available at http://www.rxabbott.com/pdf/humira.pdf.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.
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